The Center for Devices and Radiological Health (CDRH).  The CDRH is the branch of the FDA that is responsible for all medical device regulation.  This includes pediatric medical devices.

Device Classification

The FDA categorizes medical devices into one of three classes (I, II, III), based on the degree of risk they present.  As device class increases from class I to class II to class III, the regulatory controls also increase, with class I devices subject to the least regulatory control and class III devices subject to the most stringent regulatory control.  More information regarding the classification of medical devices can be found here.

The FDA has online tools to help you with your submission.

Medical devices in the United States can be Registered, Cleared, Authorized, or Approved.

Detailed below are the numerous methods for regulating devices with the relevant FDA links.  Because of the complex nature of the listing, expert guidance is necessary.

Generally, owners or operators of establishments that are involved in the production and distribution of medical devices intended for use in the U.S. are required to register annually with the FDA. This process is known as establishment registration.  More information on the FDA registration process can be found here.

Class II and I medical devices, in which the manufacturers can demonstrate their product is substantially equivalent to an existing FDA approved or cleared product, may be eligible to submit a 510K application.

  • 510(k) Submissions: A 510(k) is a premarket submission made to the FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device (section 513(i)(1)(A) FD&C Act). More information can be found here.
  • De Novo Classification Process (Evaluation of Automatic Class III Designation): The De Novo process provides a pathway to classify novel medical devices for which general controls alone, or general and special controls, provide reasonable assurance of safety and effectiveness for the intended use, but for which there is no legally marketed predicate device. This process provides an alternative pathway for devices in which there is low to moderate risk.  Devices that are classified through the De Novo pathway may be marketed and used as predicates for future 510(k) submission. More information is found here.

Most Class III and some Class I and II devices (where there is no predicate device) require FDA approval prior to marketing.  Premarket approval is based on a determination by the FDA that the application contains sufficient valid scientific evidence that provides reasonable assurance that the device is safe and effective for its intended use or uses.

  • Pre-Market Approval (PMA). Premarket approval is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of the medical device.  More information can be found here and here.
  • Humanitarian Use Device (HUD) and Humanitarian Device Exemption (HDE). The Humanitarian program applies to those medical devices intended to benefit patients in the treatment or diagnosis of a disease or condition that affects or is manifested in not more than 8,000 individuals per year as eligible for Humanitarian Device Exemption. The (HDE) application is similar in both form and content to a premarket approval (PMA) application but is exempt from the effectiveness requirements of a PMA. More information about HUD and HDE can be found here.

In the event of an emergency, the FDA may make products available based upon best available evidence, without waiting for all the evidence that would be available for an FDA approval or clearance.

  • Emergency Use Authorizations for Medical Devices (EUAs). Under extreme cases of medical emergencies, like a pandemic, the FDA can allow for the release of certain medical devices and diagnostics without the benefit of all the evidence that would establish its safety and efficacy.  More information on the topic can be found here.

Pediatric Device Development and Labeling. The FDA is committed to supporting the development and availability of safe and effective pediatric medical devices. More information on the topic can be found here.

Leveraging Existing Clinical Data for Extrapolation to Pediatric Uses of Medical Devices. The FDA provides guidance regarding the use of existing clinical data for application of medical devices to the pediatric patient population. More information can be found here.

Other Information Important to Device Development

Investigational Device Exemption (IDE). An investigational device exemption (IDE) allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data. Clinical studies are most often conducted to support a PMA. Of note, an IDE requires the approval of the Institutional Review Board (IRB). More information can be found here.

Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program. The FDA allows for innovators to interact with FDA experts to discuss specific aspects of the regulatory process and requirements. More information on the Q-Submission Program can be found here.

Breakthrough Devices Program. The Breakthrough Devices Program is a voluntary program for certain medical devices and device-led combination products that provide for more effective treatment of diagnosis of life-threatening or irreversibly debilitating diseases or conditions. The goal of this program is to provide patient and health care providers with timely access to these medical devices by speeding up their development, assessment, and review, while preserving the high regulatory standards consistent with the FDA’s mission to protect and promote public health. More information can be found here.

Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions. Describes the FDA’s current approach to considering uncertainty in making benefit-risk determinations to support FDA premarket decisions for medical device premarket approval applications (PMAs), De Novo requests, and humanitarian device exemption (HDE) applications. More information can be found here.

Early Feasibility Studies (EFS) Program. The CDRH’s EFS Program facilitates the conduct of early feasibility studies in the United States to increase access for patients to potentially beneficial technologies and to support device innovation. These studies may be used to evaluate the device design concept, with respect to clinical safety and device functionality in a small number of subjects (generally fewer than 10 subjects) when this information cannot practically be provided through traditional non-clinical assessments or appropriate nonclinical tests are unavailable. More information can be found here.

Real World Evidence (RWE). The FDA uses real world data (RWD) and real-world evidence (RWE) to monitor post-market safety, adverse events, and to make regulatory decisions. RWD are the data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources. RWD can come from a number of sources such as electronic health records, claims and billing activities, and product registries. RWE is the clinical evidence regarding the usage and potential benefit or risks of a medical product derived from analysis of RWD. More information can be found here.

Content of Premarket Submissions for Management of Cybersecurity in Medical Devices. The FDA assists the industry in identifying issues related to cybersecurity that manufacturers should consider in the design and development of their medical devices as well as in preparing premarket submissions for those devices. More information and guidance documents can be found here.

SteP (Safe Technologies Program). SteP is a new and voluntary program introduced by the FDA for certain medical devices and device-led combination products that are reasonably expected to significantly improve the safety of currently available treatments or diagnostics that target an underlying disease or condition associated with morbidities and mortalities less serious than those eligible for the Breakthrough Device Program.  More information on this program can be found here.

Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices. FDA-recognized consensus standards are standards that the FDA has vetted and determined are appropriate to support clearance or approval of a device. More information can be found here.

Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions. The Food and Drug Administration (FDA) describes relevant information that should be included in test report summaries, test protocols, and complete test reports for non-clinical bench performance testing provided in a premarket submission (i.e., premarket approval (PMA) applications, humanitarian device exemption (HDE) applications, premarket notification (510(k)) submissions, investigational device exemption (IDE) applications, and De Novo requests). Further information and a link to the appropriate Guidance Document can be found here.

Reporting of Computational Modeling Studies in Medical Device Submissions. Provides information and access to guidance documents on the formatting, organization, and content of reports of computational modeling and simulation that are used to support medical device submissions. More information can be found here.

Humanitarian Use Device (HUD) Program and Humanitarian Device Exemption (HDE).

With the release of the 2016 Century Cures Act, a device qualifies for humanitarian use designation if it is intended to treat or diagnose a disease or disorder affecting less than 8,000 people in the United States per year.  Once HUD status has been designated, the applicant can then apply for an HDE.  This process is further detailed in these links. The HUD Designation Program, HDE Program, and Education and Media Resources for the HUD Program.  A high proportion of pediatric disorders affect a limited number of persons relative to the overall population of the United States, and, as such, many devices qualify for these programs. More information regarding the HUD and HDE Program for pediatrics can be found at this link HUD and HDE for Pediatrics.

Orphan Product Development

The FDA Office of Orphan Products Development’s (OOPD) mission is to advance the evaluation and development of products (drugs, biologics, devices, or medical foods) that demonstrate promise for the diagnosis and/or treatment of rare diseases or conditions. In fulfilling that task, OOPD evaluates scientific and clinical data submissions from sponsors to identify and designate products as promising for rare disease and to further advance scientific development of such promising medical products. The office also works on rare disease issues with the medical and research communities, professional organizations, academia, governmental agencies, industry, and rare disease patient groups.